MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-29 for GASTRANIMALS 15FR REORDER #1003215 manufactured by Applied Medical Technology, Inc..
[955]
12/31/91 patient had pig insertion. Returned to surgery on 12/18/91. Patient returned to surgery for gastrorrhapy and a laparotomy and replacement of pig was performed. Invalid data - regarding single use labeling of device. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3488 |
| MDR Report Key | 3488 |
| Date Received | 1992-07-29 |
| Date of Report | 1992-01-09 |
| Date of Event | 1991-12-31 |
| Date Facility Aware | 1992-01-07 |
| Report Date | 1992-01-09 |
| Date Reported to Mfgr | 1992-01-09 |
| Date Added to Maude | 1993-04-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GASTRANIMALS |
| Generic Name | P.I.G. SILICONE INITIAL PLACEMENT GASTROSTOMY TRAY 15FR |
| Product Code | EYN |
| Date Received | 1992-07-29 |
| Model Number | 15FR |
| Catalog Number | REORDER #1003215 |
| Lot Number | 071891 |
| ID Number | NI |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3230 |
| Manufacturer | APPLIED MEDICAL TECHNOLOGY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-29 |